QC Microbiologist II

Job description

ROLE SUMMARY: The Microbiologist serves as a technical expert within the QC Microbiology organization, with responsibility for microbiological method development, transfer, and validation for biologics (peptides, and proteins including mAbs) and small molecule products across raw materials, in process samples, bulk drug substance, and finished product. This role supports the design and establishment of microbiology capabilities within a new CDMO facility and performs routine and non routine QC testing, including bioburden, endotoxin, microbial enumeration, growth promotion, sterility testing, and environmental monitoring sample testing as needed. The Microbiologist provides subject matter expertise in aseptic processing, sanitization, and sterility assurance, and supports validation of sterilization systems, cleaning processes, and environmental programs. The role leads microbiology investigations, authors technical documentation, ensures audit readiness, and mentors junior staff while maintaining strict adherence to cGMP, regulatory expectations, and site procedures. ROLE RESPONSIBILITIES: Microbiological Method Development, Validation & Transfer - Lead development, optimization,...